Our Services
AI/ML Biomarker Science and Precision Diagnostics
McGenome LLC applies its platform development expertise to collaborative projects in rare disease diagnostics, health equity biomarker research, and NIH-funded translational science.
Molecular Diagnostic Platform Development
AI/ML-integrated NGS panel design; variant classification pipeline; machine learning composite score development; CLIA kit specification; FDA De Novo 510(k) and SaMD regulatory pathway strategy.
Race-Calibrated Biomarker Analysis
Population-specific biomarker reference calibration; ancestry-stratified analysis; Fisher's Z race-equivalence testing; gnomAD South Asian and Middle Eastern allele frequency gap correction; health equity validation.
NIH STTR/SBIR Grant Strategy
Full Research Strategy preparation (Significance, Innovation, Approach); Commercialization Plan; budget development; academic partner coordination; IP section strategy for patent-pending platforms.
Rare Disease Genomics
Founder allele identification; homozygosity mapping in consanguineous cohorts; VUS reclassification using ACMG functional evidence criteria; population-specific PM2 criterion calibration for South Asian and Middle Eastern populations.
Pharma CDx Partnership Strategy
Companion diagnostic positioning for rare disease therapeutics; enrollment enrichment diagnostic design; race-neutral pharmacodynamic endpoint development; FDA Breakthrough Device designation strategy; licensing framework.
AI/ML Discovery Pipeline
GWAS/PWAS; NLP biomedical literature mining; graph neural network multi-omic integration; unsupervised endotype classification; SHAP-based interpretable ML for FDA CDS Software Guidance compliance.